| Class 2 Device Recall Sarns" SoftFlow Aortic Cannula without Suture Flange | |
Date Initiated by Firm | October 23, 2013 |
Date Posted | November 08, 2013 |
Recall Status1 |
Terminated 3 on July 18, 2014 |
Recall Number | Z-0195-2014 |
Recall Event ID |
66624 |
510(K)Number | K934127 |
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
|
Product | Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long.
Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. |
Code Information |
Catalog Number 5841 Lot Numbers 0677302 |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Rd Ann Arbor MI 48103-9586
|
For Additional Information Contact | 734-741-6173 |
Manufacturer Reason for Recall | During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications on certain product lots of Sarns" Soft-Flow Aortic Cannulae and Sarns" Venous Return Cannulae. |
FDA Determined Cause 2 | Employee error |
Action | On 10/23/13, Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE RECALL LETTER to their consignees. The letter identified the reason for the device removal, identified the affected product and associated potential hazards, and provided recall instructions to their customers regarding affected product return. Questions regarding this recall are directed to CVS Customer Service M-F, 8am-6pm at 1-800-521-2818. |
Quantity in Commerce | 30 units |
Distribution | Worldwide Distribution-USA including DC and the states of MO,TX,OK, LA, MA, CA, WI, and MI and the country of Canada. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = DWF
|
|
|
|